29 results on '"Osorio, Dimelza"'
Search Results
2. Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights
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Marsal, Josep Ramon, Urreta-Barallobre, Iratxe, Ubeda-Carrillo, Marimar, Osorio, Dimelza, Lumbreras, Blanca, Lora, David, Fernández-Felix, Borja M., Oristrell, Gerard, Ródenas-Alesina, Eduard, Herrador, Lorena, Ballesteros, Mónica, Zamora, Javier, Pijoan, Jose I., Ribera, Aida, and Ferreira-González, Ignacio
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- 2022
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3. Coste-efectividad del desfibrilador automático implantable para la prevención primaria de la muerte súbita cardiaca
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Ribera, Aida, Giménez, Emmanuel, Oristrell, Gerard, Osorio, Dimelza, Marsal, Josep Ramón, García-Pérez, Lidia, Ballesteros, Mónica, Ródenas, Eduard, Belahnech, Yassin, Escalona, Roxana, Rivas, Núria, Roca-Luque, Ivo, Ferreira-González, Ignacio, and Espallargues, Mireia
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- 2022
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4. Healthcare professionals’ opinions, barriers and facilitators towards low-value clinical practices in the hospital setting
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Osorio, Dimelza, Ribera, Aida, Solans-Domènech, Maite, Arroyo-Moliner, Liliana, Ballesteros, Mónica, and Romea-Lecumberri, Soledad
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- 2020
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5. Additional file 1 of Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights
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Marsal, Josep Ramon, Urreta-Barallobre, Iratxe, Ubeda-Carrillo, Marimar, Osorio, Dimelza, Lumbreras, Blanca, Lora, David, Fernández-Felix, Borja M., Oristrell, Gerard, Ródenas-Alesina, Eduard, Herrador, Lorena, Ballesteros, Mónica, Zamora, Javier, Pijoan, Jose I., Ribera, Aida, and Ferreira-González, Ignacio
- Abstract
Additional file 1: Supplementary material.
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- 2023
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6. Quality assessment of clinical practice guidelines for chronic kidney disease: a systematic review
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Coronado Daza, Jorge, Vernooij, Robin W. M., Salas, Karla, Osorio, Dimelza, and Urrútia Cuchí, Gerard
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- 2019
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7. Living Evidence Synthesis Baseline Report. Hospital Universitario Vall d’Hebron. LE-IHD
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Rojas- Reyes, María, Salas-Gama, Karla, Ribera, Aida, Osorio, Dimelza, Bustillos, Percy, Vargas, Laura, Rispau, Ariadna, Alonso-Fernández, Sergio, Santafe, Angie, Alonso-Coello, Pablo, Rada, Gabriel, Bendersky, Josefina, Urrutia, Gerard, Comas, David, Ávila, Camila, Verdugo, Francisca, Isern de Val, María, Benavent, Patricia, Guerra, Jorge, and Open Science Framework
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Evidence-based medicine ,Epistemonikos L.OVE Platform ,Inform Health Decisions ,circulatory assist devices mechanics ,cardiogenic shock ,Evidence Synthesis ,Medicine and Health Sciences ,cardiac arrest ,Continuos update ,Living Evidence - Abstract
Tittle: Efficacy and safety of mechanical circulatory support devices short-term ventricular assist device (VAD)/ventricular assist ECMO (VA-ECMO) in patients with acute cardiogenic shock and refractory cardiac arrest: A living overview. Authors: Karla Salas-Gama ORCID: https://orcid.org/0000-0003-4845-4899 Afilliation: Quality, Process and Innovation Direction, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain Dimelza Osorio ORCID: https://orcid.org/0000-0001-6166-647X Afilliation: Health Services Research Group, Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain Aida Ribera ORCID: https://orcid.org/0000-0002-2604-6328 Afilliation: CIBER de Epidemiología y Salud Pública (CIBERESP), Spain Percy Efrain Pantoja ORCID: https://orcid.org/0000-0003-4095-8988 Afilliation: Quality, Process and Innovation Direction, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain Mónica Ballesteros ORCID: https://orcid.org/0000-0001-5244-4795 Afilliation: Quality, Process and Innovation Direction, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain Claudia Álvarez ORCID: https://orcid.org/0000-0002-9417-6845 Afilliation: CIBER de Epidemiología y Salud Pública (CIBERESP), Spain Aitor Uribarri ORCID: https://orcid.org/0000-0002-6911-7480 Afilliation: Cardiovascular Outcomes research and Epidemiology Unit, Vall d’Hebron Institut de Recerca (VHIR), Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain Ignacio Ferreira-González ORCID: https://orcid.org/0000-0002-1208-5561 Afilliation: CIBER de Epidemiología y Salud Pública (CIBERESP), Spain Soledad Romea ORCID: https://orcid.org/0000-0002-7832-369X Afilliation: Quality, Process and Innovation Direction, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain Corresponding author: Aida Ribera Email address: aida.ribera@vhir.org Postal address: Cardiovascular Outcomes research and Epidemiology Unit, Vall d’Hebron Institut de Recerca (VHIR), Passeig Vall d'Hebron 119-129, 08035 Barcelona, Spain Funding sources/sponsors: This work is part of a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No MSCA-IF-EF-ST #894990 (to María Ximena Rojas). This work is also supported by the Hospital Universitario Vall d’Hebron. The funders and institutions did not take any part in the development of this study. Conflicts of interest: Authors have declared no conflict of interest. ABSTRACT: Objective This living overview aims to provide a timely, rigorous, and continuously updated summary of the evidence available on the role of short-term mechanical circulatory support devices and ventricular assist device (VAD) /ventricular assist ECMO (VA-ECMO) in patients with acute cardiogenic shock and refractory cardiac arrest. Design Living overview of reviews. Database The Epistemonikos-L.OVE platform was used for evidence identification, screening, and selection. This platform has been validated as a repository for COVID-19, and proved to be a highly comprehensive source of evidence. The main search source for the L.OVE platform is the Epistemonikos database (https://www.epistemonikos.org), a comprehensive database that collates information from multiple sources to identify systematic reviews and their included primary studies,including Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, DARE, HTA Database, Campbell database, JBI Database of Systematic Reviews and Implementation Reports, EPPI-Centre Evidence Library. The team maintaining the Epistemonikos-L·OVE platform devised the literature search, using the following approach: i) Identification of terms relevant to the population and intervention components of the search strategy, using Word2vec technology to the corpus of documents available in Epistemonikos Database; ii) Discussion of search terms with methods experts to identify relevant, irrelevant and missing terms, iii) Creation of a sensitive boolean strategy encompassing all the relevant terms. The results of the literature searches were automatically incorporated into the L·OVE platform (automated retrieval) and organized in the corresponding L.OVE of “Mechanical assist devices for cardiovascular diseases”. Methods We conducted a rapid overview and generated a structured evidence summary with a pre-established format that includes key messages, a summary of the body of evidence (presented as an evidence matrix in Epistemonikos), a meta-analysis of all studies (when possible), a summary table of results with the method GRADE (Grades of Recommendation, Assessment, Development and Evaluation) and a section of other considerations for decision making. Results We identified four systematic reviews that together included five randomized trials comparing VAD (TandemHeart or Impella) with respect to the best treatment option (ionotropes and/or aortic balloon counterpulsation in patients with cardiogenic shock). There are no studies evaluating the efficacy of ECMO or studies evaluating the efficacy of VAD/ECMO in situations of cardiac arrest. Results on costs or on quality of life are not reported either. The evidence provided by systematic reviews identified do not show benefit of VAD (TandemHeart or Impella) on mortality at 30 days or at six months and, instead, a higher rate of bleeding is observed. Conclusions Up to date it is not clear whether or not the Impella and Tandem-Heart circulatory assist devices reduce overall mortality at 30 days or at six months of follow-up, because the uncertainty of the existing evidence, evaluated as very low according to GRADE approach. Impella and Tandem-Heart type circulatory assist devices might slightly increase the risk of bleeding (low certainty evidence). It is not possible to clearly establish whether Impella and Tandem-Heart type circulatory support devices increase the risk of lower limb ischemia, fever or sepsis, because the certainty of the existing evidence has been assessed as very low due to impresicion. © 2022 Hospital Universitario Vall d’Hebron, Spain/ EU H2020, Living Evidence to Inform Health Decisions Project. All rights reserved.
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- 2022
8. Efficacy of mechanical circulatory support devices in persons with acute cardiogenic shock or refractory cardiac arrest: Protocol for a living overview of systematic reviews
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Santafe, Angie, Bendersky, Josefina, Salas-Gama, Karla, Osorio, Dimelza, Ribera, Aida, Uribarri, Aitor, Ferreira, Ignacio, Romea, Soledad, Alonso-Coello, Pablo, Rojas- Reyes, María, and Open Science Framework
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Living evidence ,cardiogenic shock ,Medicine and Health Sciences ,Medical devices ,overview - Abstract
Acute cardiogenic shock (CS) is a state of inadequate organ perfusion due to failure of the heart pumping mechanism. CS is caused by severe impairment of myocardial performance that results in diminished cardiac output, end‐organ hypoperfusion, and hypoxia. Clinically this presents as hypotension refractory to volume resuscitation with features of end‐organ hypoperfusion requiring pharmacological or mechanical intervention. [1] It happens in about 3.5% of patients presenting with acute heart failure and 6.6% of patients presenting with myocardial infarction [2]. Despite advances in treatment mainly by early revascularization with subsequent mortality reduction, CS remains the leading cause of death in AMI with mortality rates still approaching 40–50% according to recent registries and randomized trials [3,4] Mechanical circulatory support (MCS) devices provide hemodynamic support and maintain vital organ perfusion thus providing therapeutic options for patients with CS when pharmacologic treatment is not sufficient or not suitable. While durable devices such as left ventricular assist devices (VAD) and total artificial heart are used selectively, percutaneous short-term devices, such as Impella and veno-arterial extracorporeal membrane oxygenation (VA-ECMO) are rapidly expanding and commonly used for short term mechanical support as a bridge to recovery, or as a bridge to cardiac transplant or to definitive VAD [1,5] Another potential use of the MCS is cardiac arrest (CA). CA is defined as the cessation of cardiac mechanical activity and circulation, which can be confirmed by the absence of a detectable pulse, unresponsiveness, and absence of a normal breathing pattern. It has been estimated that each year approximately 356,500 people suffer from out-of-hospital cardiac arrest (OHCA), and 209,000 from in-hospital cardiac arrest (IHCA) in the USA. [6]. ECMO is one of the mechanical devices that has been increasingly utilized for organ and circulatory support during refractory IHCA and OHCA. [7] MCS may ensure life-saving organ perfusion, lending clinicians crucial time to identify and treat the underlying cause of cardiac arrest. Knowledge of the best current evidence will guide patient management and service planning in the hospital setting.
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- 2022
9. A survey to assess awareness and opinion of initiatives and recommendations on low-value diagnostic practices.
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Bonfill, Xavier, Salas-Gama, Karla, Requeijo, Carolina, Merchán-Galvis, Angela, Sánchez, Antonio, Medarde, Elena, Quintana, M. Jesús, the DianaHealth Study Group, Osorio, Dimelza, Romea, Soledad, Baigorri, Francisco, Urrútia, Agustín, Vega, Josep Lluis, Armario, Pedro, Fabbi, Matteo, Pérez Segarra, Anna Carol, Martret, Xavier, Vila, Miquel, Banqué, Marta, and Cossio, Yolima
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AWARENESS ,PRIMARY care ,HOSPITAL care ,QUESTIONNAIRE design ,MEDICAL specialties & specialists - Abstract
Background: The need to reduce healthcare practices that provide no value has led to the development of initiatives that generate and publish recommendations to improve the appropriateness of clinical practice by identifying potentially inappropriate services, making recommendations, and proposing improvements. DianaHealth (www.dianahealth.com) identifies, classifies, and publishes recommendations from numerous scientific societies. The purpose of this study was to determine the awareness and perceived usefulness and applicability of published recommendations on low-value diagnostic measures, as judged by physicians who are recognised clinical leaders in their respective centres.Methods: We designed a questionnaire on the diagnostic recommendations considered relevant for each medical specialty and made it available, until September 2016, on DianaHealth. The survey was administered online to clinical leaders from 25 Spanish healthcare centres (hospitals and primary care centres).Results: A total of 413 (40.0%) physicians from 34 different specialties participated. The participation rate varied between centres (range 21.1%-100.0%) and specialties (range 12.5%-78.9%). Do Not Do (57.1%) was the most widely-known initiative. Most participants (82.6%; IQR 77.9%-94.9%) stated that they knew at least one of the 12 initiatives that identify non-recommended practices, and on average they were aware of four initiatives (range 1-12). The initiatives were perceived useful by 82.4% (IQR 73.3%-90.4%), and perceived applicable by 75.6% (IQR 67.4%-86.8%). A total of 531 recommendations were assessed. Sixty-three percent (IQR 53.6%-77.5%) of participants reported they were aware of the recommendations for their corresponding specialty. A total of 84.5% (IQR 75.0%-90.0%) stated they agreed with the recommendations and 84.5% (IQR 75.0%-90.0%) considered them useful. Among those who agreed with their respective recommendations, a median of 51.5% (IQR 41.4%-60.9%) perceived the guidelines as being fully implemented, 40.1% (IQR 31.9%-46.8%) considered them partially implemented, and 7.1% (IQR 3.7%-12.9%), not implemented.Conclusions: Clinical leaders' awareness of initiatives that generate and publish recommendations to improve clinical appropriateness remains low, although they did consider them useful. In general, participants were familiar with their speciality-specific diagnostic recommendations, agreed with them, and perceived them as useful and implemented in their centres. More needs to be done to raise awareness among professionals who do not know of or apply these recommendations. [ABSTRACT FROM AUTHOR]- Published
- 2020
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10. Taules de risc cardiovascular
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Brotons, Carlos, Moral, Irene, Soriano, Núria, Cuixart, Lluís, Osorio, Dimelza, Bottaro, David, Puig, Mireia, Joaniquet, Xavier, Marcos, Albert, and Casasa, Albert
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risc ,cardiovascular ,taules - Published
- 2014
11. Bladder cancer index : Cross-cultural adaptation into Spanish and psychometric evaluation
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Schmidt, Stefanie, Riel, Ricard, Frances, Albert, Lorente Garín, José Antonio, Bonfill, X. (Xavier), Martinez Zapata, María José, Suárez Varela, María Morales, De la Cruz, Javier, Emparanza, José Ignacio, Sánchez, María José, Zamora, Javier, Ramos Goñi, Juan M., Alonso, J, Ferrer Forés, Maria Montserrat, Becerra, Virginia, Pardo Cladellas, Yolanda, Fores, M. F., Garin, O., Villagran, C. O., Suñol, R., Osorio, Dimelza, Cosp, X. B., Canovas, E., Pardo, G. S., Bolívar, I., Bachs, Jordi, Maroto, J. P., Quintana, M. J., Martínez Zapata, M. J., Lorente, C. M., Algaba, Ferran, Redorta, P., Esquena, Salvador., Puigvert, F., Vernooij, R., Martínez, A., Pijoan Zubizarreta, J. I., Martínez, L., Castro Diaz, D. M., Bastida, J. L., Pacheco, A. S., López, C. G., Cozar Olmo, J. M., Martínez, C., Chan, D. C., Sanchez Perez, M. J., Díaz Moratinos, A. I., Luis, A. M., Hervás, A., Ocaña, C. V., Varona, C., Burgos, Javier, Polo Rubio, J. A., López-Fando Lavalle, L., Jimenez Cidre, M. A., Garcia, A. M., Farras, N. P., Lopez, R. M., Garcia, S. S., Abraira, Víctor, Dos Santos, V. G., De la Cámara, A. G., Martinez, J. P., Muñoz, H. G., Cabeza Rodríguez, M. A., Díaz, I. R., Sanz Jaka, J. P., Velásquez, M. J., González, A. L., Morales, M., Camps, Carlos, Díaz, C. C., Vidal, E. M., Ballester, F. S., Juan Escudero, J. U., Peidro, J. P., Torrecilla, J. L., Ramos Campos, M. M., and Cebollada, M. M.
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Background: The Bladder Cancer Index (BCI) is so far the only instrument applicable across all bladder cancer patients, independent of tumor infiltration or treatment applied. We developed a Spanish version of the BCI, and assessed its acceptability and metric properties. Methods: For the adaptation into Spanish we used the forward and back-translation method, expert panels, and cognitive debriefing patient interviews. For the assessment of metric properties we used data from 197 bladder cancer patients from a multi-center prospective study. The Spanish BCI and the SF-36 Health Survey were self-administered before and 12 months after treatment. Reliability was estimated by Cronbach's alpha. Construct validity was assessed through the multi-trait multi-method matrix. The magnitude of change was quantified by effect sizes to assess responsiveness. Results: Reliability coefficients ranged 0.75-0.97. The validity analysis confirmed moderate associations between the BCI function and bother subscales for urinary (r = 0.61) and bowel (r = 0.53) domains; conceptual independence among all BCI domains (r ≤ 0.3); and low correlation coefficients with the SF-36 scores, ranging 0.14-0.48. Among patients reporting global improvement at follow-up, pre-post treatment changes were statistically significant for the urinary domain and urinary bother subscale, with effect sizes of 0.38 and 0.53. Conclusions: The Spanish BCI is well accepted, reliable, valid, responsive, and similar in performance compared to the original instrument. These findings support its use, both in Spanish and international studies, as a valuable and comprehensive tool for assessing quality of life across a wide range of bladder cancer patients.
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- 2014
12. Bladder cancer index: cross-cultural adaptation into Spanish and psychometric evaluation
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Schmidt, Stefanie, Riel, Ricard, Frances, Albert, Lorente Garín, José Antonio, Bonfill Cosp, Xavier, Martinez Zapata, María José, Morales Suárez-Varela, María, De la Cruz, Javier, Emparanza, José Ignacio, Sánchez-Pérez, María José, Zamora, Javier, Ramos Goñi, Juan Manuel, Alonso, Jordi, Ferrer, Montserrat, Becerra, Virginia, Pardo Cladellas, Yolanda, Garin, Olatz, Orrego Villagran, Carola, Suñol, Rosa, Osorio, Dimelza, Canovas, Esther, Sancho Pardo, Gemma, Bolívar, Ignasi, Bachs, Jordi, Maroto, Pablo, Quintana, María Jesús, Martín Lorente, Cristina, Algaba, Ferran, Palou Redorta, Joan, Esquena Fernández, Salvador, Puigvert, Fundació, Vernooij, Robin W.M., Martínez, Arnaia, Pijoan Zubizarreta, J. I., Martínez, Lorea, Castro Diaz, D. M., Bastida, J. L., Suárez Pacheco, Armando, López, C. G., Cozar Olmo, J. M, Martínez, Carmen, Chan, Daisy Chang, Sanchez Perez, M. J., Díaz Moratinos, A. I., Luis, A. M., Hervás, A., Ocaña, C. V., Varona, C., Burgos, Javier, Polo Rubio, J. A., López-Fando Lavalle, L., Jimenez Cidre, M. A., Garcia, A. M., Farras, N. P., Lopez, R. M., Garcia, S. S., Abraira, Víctor, Dos Santos, V. G., De la Cámara, A. G., Martinez, J. P., Muñoz, H. G., Cabeza Rodríguez, M. A., Díaz, I. R., Sanz Jaka, J. P., Velásquez, M. J., González, A. L., Morales, M., Camps, Carlos, Díaz, C. C., Vidal, E. M., Ballester, F. S., Juan Escudero, J. U., Peidro, J. P., Torrecilla, J. L., Ramos Campos, M. M., Cebollada, M. M., EMPARO-CU Study Group, [Schmidt,S, Alonso,J, Ferrer,M] Health Services Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain. [Schmidt,S, Alonso,J] Department of Experimental and Health Sciences, Universidad Pompeu Fabra (UPF), Barcelona, Spain. [Schmidt,S, Bonfill,X, Martinez-Zapata,MJ, Morales Suarez-Varela,M, dela Cruz,J, Emparanza,JI, Sánchez,MJ, Zamora,J, Ferrer,M] CIBER Epidemiología y Salud Pública (CIBERESP), Madrid, Spain. [Riel,R] Center of Primary Health Care El Clot, Barcelona, Spain. [Frances,A, Lorente Garin,JA] Department of Urology, Hospital del Mar, Barcelona, Spain. [Bonfill,X, Martinez-Zapata,MJ] Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. [ Bonfill,X, Ferrer,M] Universitat Autònoma de Barcelona (UAB), Barcelona, Spain. [Morales Suarez-Varela,M] Unit of Public Health and Environmental Care, Department of Preventive Medicine, University of Valencia, Valencia, Spain. [Morales Suarez-Varela,M] Center for Public Health Research (CSISP), Valencia, Spain. [dela Cruz,J] Hospital 12 de Octubre, Madrid, Spain. [Emparanza,JI] Clinical Epidemiology Unit, Hospital Universitario Donostia, BioDonostia, San Sebastian, Spain. [Sánchez,MJ] Escuela Andaluza de Salud Pública, Granada, Spain. [Sánchez,MJ] Instituto de Investigación Biosanitaria de Granada, Granada, Spain. [Zamora,J] Clinical Biostatistics Unit, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain. [Ramos Goñi,JM HTA Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain. [Ramos Goñi,JM] Health Services Research on Chronic Patients Network (REDISSEC), Bilbao, Spain., This work was supported by grants from Instituto de Salud Carlos III FEDER (PS09/02139, PS09/01204, PS09/01619, PS09/02555, PI12/00772) and from AGAUR (2012FI_B1 00177, and 2009 SGR 1095).
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Male ,Psychometrics ,Aparell urinari ,Surveys and Questionnaires ,Prospective cohort study ,Càncer ,media_common ,Language ,Cognition ,General Medicine ,Patient outcome ,Control de qualitat ,Neoplasias de la Vejiga Urinaria ,Estudios de Validación ,Psicometría ,Bufeta -- Càncer ,Female ,Psicometria ,Clinical psychology ,Cross-Cultural Comparison ,Quality of life ,medicine.medical_specialty ,Urinary bladder neoplasms ,Psychiatry and Psychology::Behavioral Disciplines and Activities::Psychological Tests::Psychometrics [Medical Subject Headings] ,Publication Characteristics::Study Characteristics::Validation Studies [Medical Subject Headings] ,Cronbach's alpha ,Disciplines and Occupations::Social Sciences::Quality of Life [Medical Subject Headings] ,medicine ,Diseases::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Urinary Bladder Neoplasms [Medical Subject Headings] ,media_common.cataloged_instance ,Humans ,European Union ,European union ,Aged ,Neoplasm Staging ,Gynecology ,Analysis of Variance ,Bladder cancer ,business.industry ,Research ,Public Health, Environmental and Occupational Health ,Construct validity ,Translating ,medicine.disease ,Cross-cultural studies ,United States ,Validation studies ,Patient outcomes ,Calidad de Vida ,business - Abstract
Background: The Bladder Cancer Index (BCI) is so far the only instrument applicable across all bladder cancer patients, independent of tumor infiltration or treatment applied. We developed a Spanish version of the BCI, and assessed its acceptability and metric properties. Methods: For the adaptation into Spanish we used the forward and back-translation method, expert panels, and cognitive debriefing patient interviews. For the assessment of metric properties we used data from 197 bladder cancer patients from a multi-center prospective study. The Spanish BCI and the SF-36 Health Survey were self-administered before and 12 months after treatment. Reliability was estimated by Cronbach’s alpha. Construct validity was assessed through the multi-trait multi-method matrix. The magnitude of change was quantified by effect sizes to assess responsiveness./nResults: Reliability coefficients ranged 0.75-0.97. The validity analysis confirmed moderate associations between the BCI function and bother subscales for urinary (r = 0.61) and bowel (r = 0.53) domains; conceptual independence among all BCI domains (r ≤ 0.3); and low correlation coefficients with the SF-36 scores, ranging 0.14-0.48. Among patients reporting global improvement at follow-up, pre-post treatment changes were statistically significant for the urinary domain and urinary bother subscale, with effect sizes of 0.38 and 0.53. Conclusions: The Spanish BCI is well accepted, reliable, valid, responsive, and similar in performance compared to the original instrument. These findings support its use, both in Spanish and international studies, as a valuable and comprehensive tool for assessing quality of life across a wide range of bladder cancer patients. This work was supported by grants from Instituto de Salud Carlos III FEDER(PS09/02139; PS09/01204; PS09/01619; PS09/02555; PI12/00772) and from AGAUR (2012FI_B1 00177; 2009 SGR 1095).
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- 2013
13. Las iniciativas de No hacer y el portal DianaSalud.com
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Osorio, Dimelza, primary and Bonfill, Xavier, additional
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- 2016
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14. DianaHealth.com, an On-Line Database Containing Appraisals of the Clinical Value and Appropriateness of Healthcare Interventions: Database Development and Retrospective Analysis
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Bonfill, Xavier, primary, Osorio, Dimelza, additional, Solà, Ivan, additional, Pijoan, Jose Ignacio, additional, Balasso, Valentina, additional, Quintana, Maria Jesús, additional, Puig, Teresa, additional, Bolibar, Ignasi, additional, Urrútia, Gerard, additional, Zamora, Javier, additional, Emparanza, José Ignacio, additional, Gómez de la Cámara, Agustín, additional, and Ferreira-González, Ignacio, additional
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- 2016
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15. Amputaciones mayores en cirugía oncológica: Análisis retrospectivo de 80 casos en el Instituto Nacional de Cancerología
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Díaz, Sandra, Lehmann, Carlos, Villamizar, Licet, Ángel, Javier, Osorio, Dimelza, and Sánchez, Alejandra
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Amputación ,Neoplasm ,Extremities ,Cáncer ,Amputation ,Extremidades ,Neoplasias ,Cancer - Abstract
Objetivo: Describir las características epidemiológicas, clínicas y de tratamiento de los pacientes con tumores de tejidos blandos, melanoma y carcinomas escamocelulares del Servicio de Seno y Tejidos Blandos del instituto nacional de Cancerologìa con amputaciones mayores de extremidades entre los años 1998 y 2008. Métodos: Se revisaron 80 historias clínicas de pacientes adultos en quienes se realizó amputación mayor de una extremidad entre enero de 1998 y diciembre de 2008, en el Servicio de Seno y Tejidos Blandos del instituto nacional de Cancerología. Resultados: Se identificaron 24 pacientes con hemipelvectomía clásica, 22 con desarticulación de cadera, 19 con desarticulación interescapulotorácica, 8 con hemihemipelvectomía y 7 con desarticulación de hombro. los diagnósticos en orden de frecuencia fueron: sarcomas de tejidos blandos, 72,5%; carcinomas escamocelulares, 21,2%; melanoma, 6,2%. la intención de la cirugía fue curativa en 50% de los casos. En los pacientes en los cuales la intención de la cirugía fue paliativa, se presentó un mayor número de complicaciones, con significancia estadística solo para necrosis de los colgajos (22,5 vs. 5% p = 0,02). la supervivencia en los pacientes con intención curativa luego del primer año de cirugía fue de 67,5 vs. 42,5% para cirugía paliativa (p = 0,038). Conclusiones: En pacientes con tumores proximales de las extremidades con imposibilidad de cirugías preservadoras, las amputaciones mayores continúan siendo una opción terapéutica válida, a pesar de su alto índice de complicaciones. Objective: To describe the epidemiological, clinical and treatment characteristics of patients with soft tissue tumours, melanoma, and squamous cell carcinomas of the Breast and Soft Tissue Department of the Instituto Nacional de Cancerología, who had major limb amputations between the years 1998 and 2008. Methods: a review was made of the clinical records of 80 patients in whom a major limb amputation was performed between January 1998 and December 2008 in the Breast and Soft Tissue Department of the Instituto Nacional de Cancerología. Results: Of the 80 patients studied, 24 had a classic hemipelvectomy, 22 with hip disarticulation, 19 with interscapular-thoracic disarticulation, 8 with hemi-hemipelvectomy, and 7 with shoulder disarticulation. The diagnoses, in order of frequency were: soft tissue sarcomas, 72.5%; squamous cell carcinomas, 21.2%; and melanoma, 6.2%. The intention of the surgery was curative in 50% of the cases. There was a greater number of complications in the patients where the intention of the surgery was palliative, with a significant significance only for necrosis of flaps (22.5% vs. 5% p=.02). The one-year survival in the patients with intention to cure surgery was 67.5% vs. 42.5% for palliative surgery (p=.038). Conclusions: in patients with tumours proximal to the limbs, where preservative surgery is impossible, major amputations continue to be a valid therapeutic option, despite its high rate of complications.
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- 2013
16. Impacto de la utilización de las diferentes tablas SCORE en el cálculo del riesgo cardiovascular
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Brotons, Carlos, primary, Moral, Irene, additional, Soriano, Núria, additional, Cuixart, Lluís, additional, Osorio, Dimelza, additional, Bottaro, David, additional, Puig, Mireia, additional, Joaniquet, Xavier, additional, Marcos, Albert, additional, and Casasa, Albert, additional
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- 2014
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17. Development of quality of care indicators from systematic reviews: the case of hospital delivery
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Bonfill, Xavier, primary, Roqué, Marta, additional, Aller, Marta Beatriz, additional, Osorio, Dimelza, additional, Foradada, Carles, additional, Vives, Àngels, additional, and Rigau, David, additional
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- 2013
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18. Pilot Implementation of Breast Cancer Early Detection Programs in Colombia
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Murillo, Raúl, primary, Díaz, Sandra, additional, Sánchez, Oswaldo, additional, Perry, Fernando, additional, Piñeros, Marion, additional, Poveda, César, additional, Salguero, Edgar, additional, and Osorio, Dimelza, additional
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- 2008
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19. Desfibrilador automático implantable para prevención primaria de la muerte súbita cardíaca en España: eficacia, seguridad y eficiencia
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Ribera Sole, Aida, Giménez-García, Emmanuel, Oristrell Santamaria, Gerard, Osorio, Dimelza, García, Lídia, Espallargues-Carreras, Mireia, Ferreira González, Ignacio, [Ribera A, Ferreira I] Unitat d’Epidemiologia Cardiovascular, Hospital Universitari Vall d’Hebron, Barcelona, Spain. Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain. Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III (ISCIII), Madrid, Spain. [Giménez E] Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQUAS), Departament de Salut, Generalitat de Catalunya, Barcelona, Spain. [Oristrell G] Servei de Cardiologia, Hospital Universitari Vall d’Hebron, Barcelona, Spain. Centro de Investigación Biomédica en Red para Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III (ISCIII), Madrid, Spain. [Osorio D] Grup d’Investigació en Serveis de Salut, Hospital Universitari Vall d’Hebron, Barcelona, Spain. Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain. Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III (ISCIII), Madrid, Spain. [García L] Unidad de Evaluación del Servicio Canario de Salud (SESCS), Santa Cruz de Tenerife, Spain. Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQUAS), Departament de Salut, Generalitat de Catalunya, Barcelona, Spain. Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain, and Departament de Salut
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Equipment and Supplies::Electrical Equipment and Supplies::Electrodes::Defibrillators::Defibrillators, Implantable [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Other subheadings::Other subheadings::/prevention & control [Other subheadings] ,Geographic Locations::Europe::Spain [GEOGRAPHICALS] ,Otros calificadores::Otros calificadores::/prevención & control [Otros calificadores] ,Desfibril·ladors cardioversors implantables - Espanya ,localizaciones geográficas::Europa (continente)::España [DENOMINACIONES GEOGRÁFICAS] ,Arrítmia - Prevenció ,enfermedades cardiovasculares::enfermedades cardíacas::paro cardíaco::muerte súbita cardíaca [ENFERMEDADES] ,Cardiovascular Diseases::Heart Diseases::Heart Arrest::Death, Sudden, Cardiac [DISEASES] ,equipos y suministros::equipos eléctricos y suministros eléctricos::electrodos::desfibriladores::desfibriladores implantables [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] - Abstract
Desfibrilador automático implantable; Muerte súbita cardíaca; Prevención primaria Implantable cardioverter defibrillator; Sudden cardiac death; Primary prevention Desfibril·lador automàtic implantable; Mort sobtada cardíaca; Prevenció primària Informe que té com a objectius analitzar nova evidència disponible i conèixer el valor actual del cost-utilitat del DAI, més el tractament mèdic convencional (TMC) enfront de TMC per a prevenció primària d’arrítmies cardíaques des de la perspectiva del Sistema Nacional de Salut (SNS). Report that report that aims to analyze new available evidence and to know the current value of the cost-utility of the Implantable Cardioverter Defibrillator (ICD) plus Conventional Medical Treatment (CCT) versus CCT for primary prevention of cardiac arrhythmias from the perspective of the Spanish National Health System (SNS). Informe que tiene como objetivo analizar nueva evidencia disponible y conocer el valor actual del coste-utilidad del Desfibrilador Automático Implantable (DAI) más Tratamiento Médico Convencional (TMC) frente a TMC para prevención primaria de arritmias cardiacas desde la perspectiva del Sistema Nacional de Salud (SNS).
20. Las iniciativas de No hacery el portal DianaSalud.com
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Osorio, Dimelza and Bonfill, Xavier
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- 2016
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21. Living Evidence Synthesis Updated Report. Hospital de la Santa Creu i Sant Pau. LE-IHD
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Rojas- Reyes, María, Vargas, Laura, Urrutia, Gerard, Rispau, Ariadna, Alonso-Fernández, Sergio, Santafe, Angie, Alonso-Coello, Pablo, Rada, Gabriel, Bendersky, Josefina, Salas-Gama, Karla, Comas, David, Ribera, Aida, Osorio, Dimelza, trujillo, laura, Ávila, Camila, Verdugo, Francisca, Isern de Val, María, Benavent, Patricia, Guerra, Jorge, and Open Science Framework
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Evidence-based medicine ,Epistemonikos L.OVE Platform ,Inform Health Decisions ,advanced ovarian cancer ,Evidence Synthesis ,Medicine and Health Sciences ,targeted therapy ,Continuos update ,Living Evidence - Abstract
Tittle: Effectiveness and safety of targeted/ biological therapy in patients with advanced ovarian cancer: A living systematic review. Authors: Laura Trujillo ORCID: [0000-0001-7345-604X] Affiliation: Programa Maestría en Investigación Clínica Aplicada a las Ciencias de la Salud. Facultad de Medicina de la Universidad Autónoma de Barcelona. Barcelona, España. Gerard Urrutia ORCID: [0000-0002-8850-0960] Affiliation: Centro Iberoamericano Cochrane, Instituto de Investigación Biomédica De Sant Pau (IIB Sant Pau), Barcelona, España. CIBER de Epidemiología Clínica y Salud Pública (CIBERESP), Barcelona, España. María Ximena Rojas ORCID: [0000-0001-5752-7653] Affiliation: Centro Iberoamericano Cochrane, Instituto de Investigación Biomédica De Sant Pau (IIB Sant Pau), Barcelona, España. Corresponding autor: Laura Trujillo Vargas E-mail address: trujillovargaslaura@gmail.com Postal address: Hospital de la Santa Creu i Sant Pau C/ Sant Antoni Maria Claret, 167. Pavellón 18, planta 0. 08025 Barcelona. España. Funding sources/sponsors: This work is part of a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No MSCA-IF-EF-ST #894990 (to María Ximena Rojas). This work is also supported by the Hospital Universitario Vall d’Hebron. The funders and institutions did not take any part in the development of this study. Conflicts of interest: Authors have declared no conflict of interest. ABSTRACT: Objective This Living Systematic review aims to evaluate the efficacy and safety of targeted therapy (Bevacizumab, Olaparib, Niraparib, Rucaparib) for patients with advanced ovarian cancer. Design Living Systematic review. Database The Epistemonikos-L.OVE platform was used for evidence identification, screening, and selection. This platform has been validated as a repository for COVID-19, and proved to be a highly comprehensive source of evidence. The main search source for the L.OVE platform is the Epistemonikos database (https://www.epistemonikos.org), a comprehensive database that collates information from multiple sources to identify systematic reviews and their included primary studies, including Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, DARE, HTA Database, Campbell database, JBI Database of Systematic Reviews and Implementation Reports, EPPI-Centre Evidence Library. The team maintaining the Epistemonikos-L·OVE platform devised the literature search, using the following approach: i) Identification of terms relevant to the population and intervention components of the search strategy, using Word2vec technology to the corpus of documents available in Epistemonikos Database; ii) Discussion of search terms with methods experts to identify relevant, irrelevant and missing terms, iii) Creation of a sensitive boolean strategy encompassing all the relevant terms. The results of the literature searches were automatically incorporated into the L·OVE platform (automated retrieval) and organized in the corresponding L.OVE of “Targeted therapies for advanced ovarian cancer”. Methods We included only randomized controlled trials (RCT) evaluating the effect of targeted therapies — versus placebo or no treatment in patients with advanced ovarian cancer. Two reviewers independently screened each study for eligibility, extracted data, and assessed the risk of bias. Measures included overall survival, Progression-free survival, toxicity and health related quality of life. We applied the GRADE approach to assess the certainty of the evidence for each outcome. This is the second update report since our previous baseline evidence synthesis report for this question, completed in 04/03/2022 and the first update report completed in 01/06/2022. Results Since the beginning of this living review, searches have retrieved [400] references to the L·OVE platform. We considered [170] as potentially eligible and [131] were reviewed in full text. The baseline report had included [14] Systematic reviews and [6] randomized clinical trial that evaluated the use of targeted therapy compared to the use of placebo in patients with advanced ovarian cancer. Two [2] new systematic reviews, including one [1] new randomized clinical trial, had been included for the previous update (Living Overview). For this new update (Living systematic review), randomized clinical trials were considered, with seven [7] studies (RCTs) in total, including 25 references. For outcome Overall Survival, analysis showed a favorable effect of targeted therapy use between groups for the BRCA population (HR 0.69; 95% CI [0.54 to 0.88]) and Progression-Free Survival outcome, the analysis showed a favorable effect of targeted therapy use between groups for the mixed population (HR 0.47; 95% CI [0.40 to 0.55]), BRCA mutated population (HR 0.29; 95% CI [0.25 to 0.33]), and without BRCA mutation (HR 0.39; 95% CI [0.33 to 0.46]). The GRADE quality of the evidence for the main outcomes was high. Conclusions The use of targeted therapy has a clear favorable effect compared to placebo on outcomes such as overall survival and progression-free survival in advanced ovarian cancer in the entire population, but more clearly in the BRCA-mutated population. Although it is true that a favorable effect on health-related quality of life was reported, they do not have a clinically relevant magnitude; and also no study reported on the outcome of disease-related symptoms. The new emerging evidence detected through the updates (RCT), it was concluded that it would be advisable to continue with the monitoring and ideally make a de novo systematic review which is what has been done in this update. © 2022 Hospital de la Santa Creu i Sant Pau, Spain/ EU H2020, Living Evidence to Inform Health Decisions Project. All rights reserved.
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- 2022
22. Living Evidence Synthesis Updated Report. Hospital Universitario Ramón y Cajal. LE-IHD
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Rojas- Reyes, María, Bendersky, Josefina, Comas, David, Gil, Andrea, Plana, Maria, Vargas, Laura, Rispau, Ariadna, Alonso-Fernández, Sergio, Santafe, Angie, Alonso-Coello, Pablo, Rada, Gabriel, Salas-Gama, Karla, Urrutia, Gerard, Ribera, Aida, Osorio, Dimelza, Ávila, Camila, Verdugo, Francisca, Isern de Val, María, Benavent, Patricia, Guerra, Jorge, and Open Science Framework
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Evidence-based medicine ,Epistemonikos L.OVE Platform ,Inform Health Decisions ,Evidence Synthesis ,Medicine and Health Sciences ,bowel inflammatory disease ,fecal microbiota transplant ,Continuos update ,Living Evidence ,ulcerative colitis - Abstract
Tittle: Effectiveness and safety of Fecal Microbiota Transplant in the Treatment of ulcerative colitis: A living systematic review. Authors: Andrea Correa-Pérez Afilliation: Clinical Biostatistics Unit. Hospital Universitario Ramón y Cajal (IRYCIS), Madrid, Spain. Faculty of Medicine. Universidad Francisco de Vitoria, Madrid, Spain Jorge de Vicente Guijarro Afilliation: Servicio de Medicina Preventiva y Salud Pública, Hospital Universitario Ramón y Cajal (IRYCIS) Madrid, Spain Andrea Gaetano Gil Afilliation: Clinical Biostatistics Unit. Hospital Universitario Ramón y Cajal (IRYCIS), Madrid, Spain Juan Ocaña Jiménez Afilliation: Servicio de Cirugía General y del Aparato Digestivo. Unidad de Coloproctología. Hospital Universitario Ramón y Cajal, Madrid, Spain Raquel Luengo González Afilliation: Department of Nursing and Physiotherapy. University of Alcalá, Madrid, Spain David Rigau Comas Afilliation: Iberoamerican Cochrane Centre. C/ Sant Antoni Maria Claret, 167. Pavelló 18, planta 0, 08025 Barcelona, Spain. CIBER de Epidemiología Clínica y Salud Pública (CIBERESP). Josefina Bendersky Afilliation: Institut d'Recerca-Servei d'Epidemiologia Clínica i Salut Pública. Hospital de la Santa Creu i Sant Pau. Carrer de Sant Quintí, 89, 08041 Barcelona, Spain María Ximena Rojas Reyes Afilliation: Institut d'Recerca-Servei d'Epidemiologia Clínica i Salut Pública. Hospital de la Santa Creu i Sant Pau. Carrer de Sant Quintí, 89, 08041 Barcelona, Spain María N Plana Farrás Afilliation: Unidad de Evaluación de Tecnologías Sanitarias, Ramón y Cajal University Hospital (IRYCIS), Madrid, Spain. CIBER Epidemiology and Public Health (CIBERESP) Corresponding author: Maria N Plana Farrás. Email address: nieves.plana@salud.madrid.org Postal address: Unidad de Evaluación de Tecnologías Sanitarias, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, España. CIBER de Epidemiología y Salud Pública (CIBERESP). Funding sources/sponsors: This work is part of a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No MSCA-IF-EF-ST #894990 (to María Ximena Rojas). This work is also supported by the Health Tecnology Assesment Unit of the Hospital Universitario Ramón y Cajal. The funders and institutions did not take any part in the development of this study. Conflicts of interest: Authors have declared no conflict of interest. ABSTRACT: Objective This living systematic review aims to provide a timely, rigorous, and continuously updated summary of the evidence available on the role of fecal microbiota transplant (FMT) for treatment of patients with moderate to severe ulcerative colitis (UC). Design Living systematic review. Database The Epistemonikos-L.OVE platform was used for evidence identification, screening, and selection. This platform has been validated as a repository for COVID-19, and proved to be a highly comprehensive source of evidence. The main search source for the L.OVE platform is the Epistemonikos database (https://www.epistemonikos.org), a comprehensive database that collates information from multiple sources to identify systematic reviews and their included primary studies, including Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, DARE, HTA Database, Campbell database, JBI Database of Systematic Reviews and Implementation Reports, EPPI-Centre Evidence Library. The team maintaining the Epistemonikos-L·OVE platform devised the literature search, using the following approach: i) Identification of terms relevant to the population and intervention components of the search strategy, using Word2vec technology to the corpus of documents available in Epistemonikos Database; ii) Discussion of search terms with methods experts to identify relevant, irrelevant and missing terms, iii) Creation of a sensitive boolean strategy encompassing all the relevant terms. The results of the literature searches were automatically incorporated into the L·OVE platform (automated retrieval) and organized in the corresponding L.OVE of “Fecal microbiota transplant for ulcerative colitis”. Methods To prioritize the fecal microbiota transplantation administration route, comparators and outcomes more relevant for supporting the clinical decisions in the treatment of ulcerative colitis patients, we performed a Delphi process conducted by an expert panel in the field of gastroenterology and colorectal surgery. Given Delphi panel results, we decided to include randomized studies evaluating the efficacy and safety of FMT versus any active treatment in patients with moderate to severe ulcerative colitis. Measures included clinical remission, clinical relapse, endoscopic release, clinical response, free time without corticosteroid treatment, serious adverse events and health related quality of life. Two reviewers independently screened each study for eligibility. We planned to extract data and assess the risk of bias using the ROB-2 tool by duplicate. We also planned to apply the GRADE approach to assess the certainty of the evidence for each outcome. This is the first update report since our previous baseline evidence synthesis report for this question. Last search date 11/07/2022. Results Since the beginning of this living review, searches have retrieved 202 references to the L·OVE platform. 28 were considered potentially eligible and 16 were reviewed in full text. The initial baseline report did not include any randomized clinical trial that evaluated the use of FMT compared to the use of any active treatment in patients with moderate to severe ulcerative colitis. No new randomized clinical trials were included for this update. Conclusions No randomized trials evaluating the effect of FMT versus any active treatment in patients with moderate to severe ulcerative colitis have been identified. As of this update, this Living Systematic Review will be withdrawn from the living model, as research on the review (PICO) question is not emerging. © 2022 Hospital Universitario Ramón y Cajal, Spain/ EU H2020, Living Evidence to Inform Health Decisions Project. All rights reserved.
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- 2022
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23. Living Evidence Synthesis Baseline Report. Hospital Universitario Ramón y Cajal. LE-IHD
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Rojas- Reyes, María, Bendersky, Josefina, Comas, David, Gil, Andrea, Plana, Maria, Vargas, Laura, Rispau, Ariadna, Alonso-Fernández, Sergio, Santafe, Angie, Alonso-Coello, Pablo, Rada, Gabriel, Salas-Gama, Karla, Urrutia, Gerard, Ribera, Aida, Osorio, Dimelza, Ávila, Camila, Verdugo, Francisca, Isern de Val, María, Benavent, Patricia, Guerra, Jorge, and Open Science Framework
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Evidence-based medicine ,Inform Health Decisions ,Ulcerative colitis ,Evidence Synthesis ,Medicine and Health Sciences ,fecal microbiota transplant ,Continuos update ,Living Evidence - Abstract
Tittle: Effectiveness and safety of Fecal Microbiota Transplant in the Treatment of ulcerative colitis: A living overview. Authors: Andrea Correa-Pérez Afilliation: Clinical Biostatistics Unit. Hospital Universitario Ramón y Cajal (IRYCIS), Madrid, Spain. Faculty of Medicine. Universidad Francisco de Vitoria, Madrid, Spain Jorge de Vicente Guijarro Afilliation: Servicio de Medicina Preventiva y Salud Pública, Hospital Universitario Ramón y Cajal (IRYCIS) Madrid, Spain Andrea Gaetano Gil Afilliation: Clinical Biostatistics Unit. Hospital Universitario Ramón y Cajal (IRYCIS), Madrid, Spain Juan Ocaña Jiménez Afilliation: Servicio de Cirugía General y del Aparato Digestivo. Unidad de Coloproctología. Hospital Universitario Ramón y Cajal, Madrid, Spain Raquel Luengo González Afilliation: Department of Nursing and Physiotherapy. University of Alcalá, Madrid, Spain David Rigau Comas Afilliation: Iberoamerican Cochrane Centre. C/ Sant Antoni Maria Claret, 167. Pavelló 18, planta 0, 08025 Barcelona, Spain. CIBER de Epidemiología Clínica y Salud Pública (CIBERESP). Josefina Bendersky Afilliation: Institut d'Recerca-Servei d'Epidemiologia Clínica i Salut Pública. Hospital de la Santa Creu i Sant Pau. Carrer de Sant Quintí, 89, 08041 Barcelona, Spain María Ximena Rojas Reyes Afilliation: Institut d'Recerca-Servei d'Epidemiologia Clínica i Salut Pública. Hospital de la Santa Creu i Sant Pau. Carrer de Sant Quintí, 89, 08041 Barcelona, Spain María N Plana Farrás ORCID: 0000-0003-0921-7954 Afilliation: Unidad de Evaluación de Tecnologías Sanitarias, Ramón y Cajal University Hospital (IRYCIS), Madrid, Spain. CIBER Epidemiology and Public Health (CIBERESP) Corresponding author: Maria N Plana Farrás. Email address: nieves.plana@salud.madrid.org Postal address: Unidad de Evaluación de Tecnologías Sanitarias, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, España. CIBER de Epidemiología y Salud Pública (CIBERESP). Funding sources/sponsors: This work is part of a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No MSCA-IF-EF-ST #894990 (to María Ximena Rojas). This work is also supported by the Health Tecnology Assesment Unit of the Hospital Universitario Ramón y Cajal. The funders and institutions did not take any part in the development of this study. Conflicts of interest: Authors have declared no conflict of interest. ABSTRACT: Objective This living overview bring together all the evidence from systematic reviews assessing the effectiveness and safety of fecal microbiota transplantation (FMT) in patients with ulcerative colitis (UC). Particularly, in patients with moderate to severe UC refractary to corticosteroids treatment. Is in these patients where TMF has been proposed as a therapeutic alternative to improve the inflammation control. Design Living overview of reviews. Database The Epistemonikos-L.OVE platform was used for evidence identification, screening, and selection. This platform has been validated as a repository for COVID-19, and proved to be a highly comprehensive source of evidence. The main search source for the L.OVE platform is the Epistemonikos database (https://www.epistemonikos.org), a comprehensive database that collates information from multiple sources to identify systematic reviews and their included primary studies, including Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, DARE, HTA Database, Campbell database, JBI Database of Systematic Reviews and Implementation Reports, EPPI-Centre Evidence Library. The team maintaining the Epistemonikos-L·OVE platform devised the literature search, using the following approach: i) Identification of terms relevant to the population and intervention components of the search strategy, using Word2vec technology to the corpus of documents available in Epistemonikos Database; ii) Discussion of search terms with methods experts to identify relevant, irrelevant and missing terms, iii) Creation of a sensitive boolean strategy encompassing all the relevant terms. The results of the literature searches were automatically incorporated into the L·OVE platform (automated retrieval) and organized in the corresponding L.OVE of “Fecal microbiota transplant for ulcerative colitis”. Methods We conducted a rapid overview and generated an structured evidence summary following a pre-established format that includes key messages, a summary of the body of evidence (presented as an evidence matrix in Epistemonikos), a meta-analysis of all studies (when possible), a summary table of results with the method GRADE (Grades of Recommendation, Assessment, Development and Evaluation) and a section of other considerations for decision making. Results We identified 16 systematic reviews that together included 79 primary studies, five of which were randomized clinical trials comparing FMT with placebo thefore were considered for analysis. Fecal microbiota transplant compared to placebo in patients with moderate to severe UC could increase the proportion of patients with clinical remission (RR 1.80, 95% CI (1.24 to 2.61)) and clinical remission with endoscopic response/remission ( RR 2.89, 95% CI (1.63 to 5.14)). There is uncertainty about the risk of serious adverse events associated with fecal microbiota transplant (RR 1.40, 95% CI (0.55 to 3.58)) very low certainty of the evidence due to inconsistency and impresicion. Conclusions This summary results are partially consistent with the identified systematic reviews . Fecal microbiota transplant showed to increase the proportion of patients with clinical remission and/or endoscopic response. There is uncertainty about the risk of serious adverse events related to the intervention. The certainty of the evidence is low or very low. © 2022 Hospital Universitario Ramón y Cajal, Spain/ EU H2020, Living Evidence to Inform Health Decisions Project. All rights reserved.
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- 2022
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24. Exercise training for adult lung transplant recipients.
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Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, and Seron P
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- Bias, Bone Density, Cause of Death, Exercise Tolerance, Female, Forced Expiratory Volume, Humans, Male, Middle Aged, Muscle Strength, Program Evaluation, Quality of Life, Randomized Controlled Trials as Topic, Resistance Training, Time Factors, Walk Test, Exercise, Lung Transplantation rehabilitation, Transplant Recipients
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Background: Pulmonary transplantation is the final treatment option for people with end-stage respiratory diseases. Evidence suggests that exercise training may contribute to speeding up physical recovery in adults undergoing lung transplantation, helping to minimize or resolve impairments due to physical inactivity in both the pre- and post-transplant stages. However, there is a lack of detailed guidelines on how exercise training should be carried out in this specific sub-population., Objectives: To determine the benefits and safety of exercise training in adult patients who have undergone lung transplantation, measuring the maximal and functional exercise capacity; health-related quality of life; adverse events; patient readmission; pulmonary function; muscular strength; pathological bone fractures; return to normal activities and death., Search Methods: We searched the Cochrane Kidney and Transplant Specialised Register up to 6 October 2020 using relevant search terms for this review. Studies in the CKTR are identified through CENTRAL, MEDLINE, and EMBASE searches, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov., Selection Criteria: Randomised controlled trials (RCTs) were included comparing exercise training with usual care or no exercise training, or with another exercise training program in terms of dosage, modality, program length, or use of supporting exercise devices. The study population comprised of participants older than 18 years who underwent lung transplantation independent of their underlying respiratory pathology., Data Collection and Analysis: Two authors independently reviewed all records identified by the search strategy and selected studies that met the eligibility criteria for inclusion in this review. In the first instance, the disagreements were resolved by consensus, and if this was not possible the decision was taken by a third reviewer. The same reviewers independently extracted outcome data from included studies and assessed risk of bias. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach., Main Results: Eight RCTs (438 participants) were included in this review. The median sample size was 60 participants with a range from 16 to 83 participants. The mean age of participants was 54.9 years and 51.9% of the participants were male. The median duration of the exercise training programs for the groups undergoing the intervention was 13 weeks, and the median duration of training in the active control groups was four weeks. Overall the risk of bias was considered to be high, mainly due to the inability to blind the study participants and the selective reporting of the results. Due to small number of studies included in this review, and the heterogeneity of the intervention and outcomes, we did not obtain a summary estimate of the results. Two studies comparing resistance exercise training with no exercise reported increases in muscle strength and bone mineral density (surrogate outcomes for pathological bone fractures) with exercise training (P > 0.05), but no differences in adverse events. Exercise capacity, health-related quality of life (HRQoL), pulmonary function, and death (any cause) were not reported. Three studies compared two different resistant training programs. Two studies comparing squats using a vibration platform (WBVT) compared to squats on the floor reported an improvement in 6-minute walk test (6MWT) (28.4 metres, 95% CI 3 to 53.7; P = 0.029; and 28.3 metres, 95% CI 10.0 to 46.6; P < 0.05) with the WBVT. Supervised upper limb exercise (SULP) program improved 6MWT at 6 months compared to no supervised upper limb exercise (NULP) (SULP group: 561.2 ± 83.6 metres; NULP group: 503.5 ± 115.2 metres; P = 0.01). There were no differences in HRQoL, adverse events, muscular strength, or death (any cause). Pulmonary function and pathological bone fractures were not reported. Two studies comparing multimodal exercise training with no exercise reported improvement in 6MWT at 3 months (P = 0.008) and at 12-months post-transplant (P = 0.002) and muscular strength (quadriceps force (P = 0.001); maximum leg press (P = 0.047)) with multimodal exercise, but no improvement in HRQoL, adverse events, pulmonary function, pathological bone fractures (lumbar T-score), or death (any cause). One study comparing the same multimodal exercise programs given over 7 and 14 weeks reported no differences in 6MWT, HRQoL, adverse events, pulmonary function, muscle strength, or death (any cause). Pathological bone fractures were not reported. According to GRADE criteria, we rated the certainty of the evidence as very low, mainly due to the high risk of bias and serious imprecision., Authors' Conclusions: In adults undergoing lung transplantation the evidence about the effects of exercise training is very uncertain in terms of maximal and functional exercise capacity, HRQoL and safety, due to very imprecise estimates of effects and high risk of bias., (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)
- Published
- 2021
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25. Surgery versus stereotactic radiotherapy for people with single or solitary brain metastasis.
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Fuentes R, Osorio D, Expósito Hernandez J, Simancas-Racines D, Martinez-Zapata MJ, and Bonfill Cosp X
- Subjects
- Brain Neoplasms mortality, Combined Modality Therapy methods, Combined Modality Therapy mortality, Cranial Irradiation methods, Cranial Irradiation mortality, Humans, Progression-Free Survival, Radiosurgery adverse effects, Radiosurgery mortality, Randomized Controlled Trials as Topic, Brain Neoplasms radiotherapy, Brain Neoplasms secondary, Brain Neoplasms surgery, Radiosurgery methods
- Abstract
Background: Brain metastases occur when cancer cells spread from their original site to the brain and are a frequent cause of morbidity and death in people with cancer. They occur in 20% to 40% of people during the course of their disease. Brain metastases are also the most frequent type of brain malignancy. Single and solitary brain metastasis is infrequent and choosing the most appropriate treatment is a clinical challenge. Surgery and stereotactic radiotherapy are two options. For surgery, tumour resection is performed using microsurgical techniques, while in stereotactic radiotherapy, external ionising radiation beams are precisely focused on the brain metastasis. Stereotactic radiotherapy may be given as a single dose, also known as single dose radiosurgery, or in a number of fractions, also known as fractionated stereotactic radiotherapy. There is uncertainty regarding which treatment (surgery or stereotactic radiotherapy) is more effective for people with single or solitary brain metastasis., Objectives: To assess the effectiveness and safety of surgery versus stereotactic radiotherapy for people with single or solitary brain metastasis., Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, March 2018), MEDLINE and Embase up to 25 March 2018 for relevant studies. We also searched trials databases, grey literature and handsearched relevant literature., Selection Criteria: We included randomised controlled trials (RCTs) comparing surgery versus stereotactic radiotherapy, either a single fraction (stereotactic radiosurgery) or multiple fractions (fractionated stereotactic radiotherapy) for treatment of single or solitary brain metastasis., Data Collection and Analysis: Two review authors screened all references, evaluated the quality of the included studies using the Cochrane tool for assessing risk of bias, and performed data extraction. The primary outcomes were overall survival and adverse events. Secondary outcomes included progression-free survival and quality of life . We analysed overall survival and progression-free survival as hazard ratios (HRs) with 95% confidence intervals (CIs), and analysed adverse events as risk ratios (RRs). For quality of life we used mean difference (MD)., Main Results: Two RCTs including 85 participants met our inclusion criteria. One study included people with single untreated brain metastasis (n = 64), and the other included people with solitary brain metastasis (22 consented to randomisation and 21 were analysed). We identified a third trial reported as completed and pending results this may be included in future updates of this review. The two included studies were prematurely closed due to poor participant accrual. One study compared surgery plus whole brain radiotherapy (WBRT) versus stereotactic radiosurgery alone, and the second study compared surgery plus WBRT versus stereotactic radiosurgery plus WBRT. Meta-analysis was not possible due to clinical heterogeneity between trial interventions. The overall certainty of evidence was low or very low for all outcomes due to high risk of bias and imprecision.We found no difference in overall survival in either of the two comparisons. For the comparison of surgery plus WBRT versus stereotactic radiosurgery alone: HR 0.92, 95% CI 0.48 to 1.77; 64 participants, very low-certainty evidence. We downgraded the certainty of the evidence to very low due to risk of bias and imprecision. For the comparison of surgery plus WBRT versus stereotactic radiosurgery plus WBRT: HR 0.53, 95% CI 0.20 to 1.42; 21 participants, low-certainty evidence. We downgraded the certainty of the evidence to low due to imprecision. Adverse events were reported in both trial groups in the two studies, showing no differences for surgery plus WBRT versus stereotactic radiosurgery alone (RR 0.31, 95% CI 0.07 to 1.44; 64 participants) and for surgery plus WBRT versus stereotactic radiosurgery plus WBRT (RR 0.37, 95% CI 0.05 to 2.98; 21 participants). Most of the adverse events were related to radiation toxicities. We considered the certainty of the evidence from the two comparisons to be very low due to risk of bias and imprecision.There was no difference in progression-free survival in the study comparing surgery plus WBRT versus stereotactic radiosurgery plus WBRT (HR 0.55, 95% CI 0.22 to 1.38; 21 participants, low-certainty evidence). We downgraded the evidence to low certainty due to imprecision. This outcome was not clearly reported for the other comparison. In general, there were no differences in quality of life between the two studies. The study comparing surgery plus WBRT versus stereotactic radiosurgery plus WBRT found no differences after two months using the QLQ-C30 global scale (MD -10.80, 95% CI -44.67 to 23.07; 14 participants, very low-certainty evidence). We downgraded the certainty of evidence to very low due to risk of bias and imprecision., Authors' Conclusions: Currently, there is no definitive evidence regarding the effectiveness and safety of surgery versus stereotactic radiotherapy on overall survival, adverse events, progression-free survival and quality of life in people with single or solitary brain metastasis, and benefits must be decided on a case-by-case basis until well powered and designed trials are available. Given the difficulties in participant accrual, an international multicentred approach should be considered for future studies.
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- 2018
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26. Interventions for treating acute high altitude illness.
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Simancas-Racines D, Arevalo-Rodriguez I, Osorio D, Franco JV, Xu Y, and Hidalgo R
- Subjects
- Acetazolamide therapeutic use, Acute Disease, Adolescent, Adult, Amines therapeutic use, Anticonvulsants therapeutic use, Atmospheric Pressure, Cyclohexanecarboxylic Acids therapeutic use, Dexamethasone therapeutic use, Gabapentin, Glucocorticoids therapeutic use, Humans, Hypertension, Pulmonary therapy, Magnesium therapeutic use, Randomized Controlled Trials as Topic, gamma-Aminobutyric Acid therapeutic use, Altitude Sickness therapy
- Abstract
Background: Acute high altitude illness is defined as a group of cerebral and pulmonary syndromes that can occur during travel to high altitudes. It is more common above 2500 metres, but can be seen at lower elevations, especially in susceptible people. Acute high altitude illness includes a wide spectrum of syndromes defined under the terms 'acute mountain sickness' (AMS), 'high altitude cerebral oedema' and 'high altitude pulmonary oedema'. There are several interventions available to treat this condition, both pharmacological and non-pharmacological; however, there is a great uncertainty regarding their benefits and harms., Objectives: To assess the clinical effectiveness, and safety of interventions (non-pharmacological and pharmacological), as monotherapy or in any combination, for treating acute high altitude illness., Search Methods: We searched CENTRAL, MEDLINE, Embase, LILACS, ISI Web of Science, CINAHL, Wanfang database and the World Health Organization International Clinical Trials Registry Platform for ongoing studies on 10 August 2017. We did not apply any language restriction., Selection Criteria: We included randomized controlled trials evaluating the effects of pharmacological and non-pharmacological interventions for individuals suffering from acute high altitude illness: acute mountain sickness, high altitude pulmonary oedema or high altitude cerebral oedema., Data Collection and Analysis: Two review authors independently assessed the eligibility of study reports, the risk of bias for each and performed the data extraction. We resolved disagreements through discussion with a third author. We assessed the quality of evidence with GRADE., Main Results: We included 13 studies enrolling a total of 468 participants. We identified two ongoing studies. All studies included adults, and two studies included both teenagers and adults. The 13 studies took place in high altitude areas, mostly in the European Alps. Twelve studies included participants with acute mountain sickness, and one study included participants with high altitude pulmonary oedema. Follow-up was usually less than one day. We downgraded the quality of the evidence in most cases due to risk of bias and imprecision. We report results for the main comparisons as follows.Non-pharmacological interventions (3 studies, 124 participants)All-cause mortality and complete relief of AMS symptoms were not reported in the three included trials. One study in 64 participants found that a simulated descent of 193 millibars versus 20 millibars may reduce the average of symptoms to 2.5 vs 3.1 units after 12 hours of treatment (clinical score ranged from 0 to 11 ‒ worse; reduction of 0.6 points on average with the intervention; low quality of evidence). In addition, no complications were found with use of hyperbaric chambers versus supplementary oxygen (one study; 29 participants; low-quality evidence).Pharmacological interventions (11 trials, 375 participants)All-cause mortality was not reported in the 11 included trials. One trial found a greater proportion of participants with complete relief of AMS symptoms after 12 and 16 hours when dexamethasone was administered in comparison with placebo (47.1% versus 0%, respectively; one study; 35 participants; low quality of evidence). Likewise, when acetazolamide was compared with placebo, the effects on symptom severity was uncertain (standardized mean difference (SMD) -1.15, 95% CI -2.56 to 0.27; 2 studies, 25 participants; low-quality evidence). One trial of dexamethasone in comparison with placebo in 35 participants found a reduction in symptom severity (difference on change in the AMS score: 3.7 units reported by authors; moderate quality of evidence). The effects from two additional trials comparing gabapentin with placebo and magnesium with placebo on symptom severity at the end of treatment were uncertain. For gabapentin versus placebo: mean visual analogue scale (VAS) score of 2.92 versus 4.75, respectively; 24 participants; low quality of evidence. For magnesium versus placebo: mean scores of 9 and 10.3 units, respectively; 25 participants; low quality of evidence). The trials did not find adverse events from either treatment (low quality of evidence). One trial comparing magnesium sulphate versus placebo found that flushing was a frequent event in the magnesium sulphate arm (percentage of flushing: 75% versus 7.7%, respectively; one study; 25 participants; low quality of evidence)., Authors' Conclusions: There is limited available evidence to determine the effects of non-pharmacological and pharmacological interventions in treating acute high altitude illness. Low-quality evidence suggests that dexamethasone and acetazolamide might reduce AMS score compared to placebo. However, the clinical benefits and harms related to these potential interventions remain unclear. Overall, the evidence is of limited practical significance in the clinical field. High-quality research in this field is needed, since most trials were poorly conducted and reported.
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- 2018
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27. [Do not do initiatives and the DianaSalud.com portal].
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Osorio D and Bonfill X
- Subjects
- Humans, Internet
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- 2016
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28. Leukoreduction for the prevention of adverse reactions from allogeneic blood transfusion.
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Simancas-Racines D, Osorio D, Martí-Carvajal AJ, and Arevalo-Rodriguez I
- Subjects
- Adolescent, Adult, Cause of Death, Female, Humans, Infections etiology, Male, Randomized Controlled Trials as Topic, Erythrocyte Transfusion adverse effects, Leukocyte Reduction Procedures
- Abstract
Background: A blood transfusion is an acute intervention, implemented to solve life and health-threatening conditions on a short-term basis. However, blood transfusions have adverse events, some of them potentially related to immune modulation or to a direct transmission of infectious agents (e.g. cytomegalovirus). Leukoreduction is a process in which the white blood cells are intentionally reduced in packed red blood cells (PRBCs) in order to reduce the risk of adverse reactions. The potential benefits of leukoreduced PRBCs in all types of transfused patients for decreasing infectious and non-infectious complications remain unclear., Objectives: To determine the clinical effectiveness of leukoreduction of packed red blood cells for preventing adverse reactions following allogeneic blood transfusion., Search Methods: We ran the most recent search on 10th November 2015. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE (OvidSP), Embase(OvidSP), CINAHL Plus (EBSCO), LILACS (BIREME), and clinical trials registers. In addition, we checked the reference lists of all relevant trials and reviews identified in the literature searches., Selection Criteria: Randomised clinical trials including patients of all ages requiring PRBC allogeneic transfusion. Any study was eligible for inclusion, regardless of the length of participant follow-up or country where the study was performed. The primary outcome was transfusion-related acute lung injury (TRALI). Secondary outcomes were death from any cause, infection from any cause, non-infectious complications and any other adverse event., Data Collection and Analysis: At least two review authors independently performed study selection, 'Risk of bias' assessments and data extraction. We estimated pooled relative risk for dichotomous outcomes, and we measured statistical heterogeneity using I² statistic. The random-effects model was used to synthesise results. We conducted a trial sequential analysis to assess the risk of random errors in cumulative meta-analyses., Main Results: Thirteen studies, most including adult patients, met the eligibility criteria. We found no clear evidence of an effect of leukoreduced PRBC versus non-leukoreduced PRBC in patients that were randomised to receive transfusion for the following outcomes: TRALI: RR 0.96, 95% CI 0.67 to 1.36, P = 0.80 from one trial reporting data on 1864 trauma patients. The accrued information of 1864 participants constituted only 28.5% of the diversity-adjusted required information size (DARIS) of 6548 participants. The quality of evidence was low. Death from any cause: RR 0.81, 95% CI 0.58 to 1.12, I² statistic = 63%, P = 0.20 from nine trials reporting data on 6485 cardiovascular surgical patients, gastro-oncology surgical patients, trauma patients and HIV infected patients. The accrued information of 6485 participants constituted only 55.3% of the DARIS of 11,735 participants. The quality of evidence was very low. Infection from any cause: RR 0.80, 95% CI 0.62 to 1.03, I² statistic = 84%, P = 0.08 from 10 trials reporting data on 6709 cardiovascular surgical patients, gastro-oncology surgical patients, trauma patients and HIV infected patients. The accrued information of 6709 participants constituted only 60.6% of the DARIS of 11,062 participants. The quality of evidence was very low. Adverse events: The only adverse event reported as an adverse event was fever (RR 0.81, 95% CI 0.64 to 1.02; I² statistic= 0%, P = 0.07). Fever was reported in two trials on 634 cardiovascular surgical and gastro-oncology surgical patients. The accrued information of 634 participants constituted only 84.4% of the DARIS of 751 participants. The quality of evidence was low. Incidence of other non-infectious complications: This outcome was not assessed in any included trial., Authors' Conclusions: There is no clear evidence for supporting or rejecting the routine use of leukoreduction in all patients requiring PRBC transfusion for preventing TRALI, death, infection, non-infectious complications and other adverse events. As the quality of evidence is very low to low, more evidence is needed before a definitive conclusion can be drawn.
- Published
- 2015
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29. Drug therapy for treating post-dural puncture headache.
- Author
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Basurto Ona X, Osorio D, and Bonfill Cosp X
- Subjects
- Adrenocorticotropic Hormone therapeutic use, Adult, Amines therapeutic use, Blood Patch, Epidural methods, Caffeine therapeutic use, Cyclohexanecarboxylic Acids therapeutic use, Female, Gabapentin, Humans, Hydrocortisone therapeutic use, Male, Middle Aged, Pain Measurement methods, Randomized Controlled Trials as Topic, Sumatriptan therapeutic use, Theophylline therapeutic use, Treatment Outcome, gamma-Aminobutyric Acid therapeutic use, Analgesics therapeutic use, Post-Dural Puncture Headache drug therapy, Spinal Puncture adverse effects
- Abstract
Background: This is an updated version of the original Cochrane review published in Issue 8, 2011, on 'Drug therapy for treating post-dural puncture headache'.Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture, an invasive procedure frequently performed in the emergency room. Numerous pharmaceutical drugs have been proposed to treat PDPH but there are still some uncertainties about their clinical effectiveness., Objectives: To assess the effectiveness and safety of drugs for treating PDPH in adults and children., Search Methods: The searches included the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE and MEDLINE in Process (from 1950 to 29 July 2014), EMBASE (from 1980 to 29 July 2014) and CINAHL (from 1982 to July 2014). There were no language restrictions., Selection Criteria: We considered randomised controlled trials (RCTs) assessing the effectiveness of any pharmacological drug used for treating PDPH. Outcome measures considered for this review were: PDPH persistence of any severity at follow-up (primary outcome), daily activity limited by headache, conservative supplementary therapeutic option offered, epidural blood patch performed, change in pain severity scores, improvements in pain severity scores, number of days participants stay in hospital, any possible adverse events and missing data., Data Collection and Analysis: Review authors independently selected studies, assessed risk of bias and extracted data. We estimated risk ratios (RR) for dichotomous data and mean differences (MD) for continuous outcomes. We calculated a 95% confidence interval (CI) for each RR and MD. We did not undertake meta-analysis because the included studies assessed different sorts of drugs or different outcomes. We performed an intention-to-treat (ITT) analysis., Main Results: We included 13 small RCTs (479 participants) in this review (at least 274 participants were women, with 118 parturients after a lumbar puncture for regional anaesthesia). In the original version of this Cochrane review, only seven small RCTs (200 participants) were included. Pharmacological drugs assessed were oral and intravenous caffeine, subcutaneous sumatriptan, oral gabapentin, oral pregabalin, oral theophylline, intravenous hydrocortisone, intravenous cosyntropin and intramuscular adrenocorticotropic hormone (ACTH).Two RCTs reported data for PDPH persistence of any severity at follow-up (primary outcome). Caffeine reduced the number of participants with PDPH at one to two hours when compared to placebo. Treatment with caffeine also decreased the need for a conservative supplementary therapeutic option.Treatment with gabapentin resulted in better visual analogue scale (VAS) scores after one, two, three and four days when compared with placebo and also when compared with ergotamine plus caffeine at two, three and four days. Treatment with hydrocortisone plus conventional treatment showed better VAS scores at six, 24 and 48 hours when compared with conventional treatment alone and also when compared with placebo. Treatment with theophylline showed better VAS scores compared with acetaminophen at two, six and 12 hours and also compared with conservative treatment at eight, 16 and 24 hours. Theophylline also showed a lower mean "sum of pain" when compared with placebo. Sumatriptan and ACTH did not show any relevant effect for this outcome.Theophylline resulted in a higher proportion of participants reporting an improvement in pain scores when compared with conservative treatment.There were no clinically significant drug adverse events.The rest of the outcomes were not reported by the included RCTs or did not show any relevant effect., Authors' Conclusions: None of the new included studies have provided additional information to change the conclusions of the last published version of the original Cochrane review. Caffeine has shown effectiveness for treating PDPH, decreasing the proportion of participants with PDPH persistence and those requiring supplementary interventions, when compared with placebo. Gabapentin, hydrocortisone and theophylline have been shown to decrease pain severity scores. Theophylline has also been shown to increase the proportion of participants that report an improvement in pain scores when compared with conventional treatment.There is a lack of conclusive evidence for the other drugs assessed (sumatriptan, adrenocorticotropic hormone, pregabalin and cosyntropin).These conclusions should be interpreted with caution, due to the lack of information to allow correct appraisal of risk of bias, the small sample sizes of the studies and also their limited generalisability, as nearly half of the participants were postpartum women in their 30s.
- Published
- 2015
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